Acute Effects of LBBP Versus BVP for CRT

Heart Failure Clinical Trial

Official title:

Acute Effects of Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04505384
• Other study ID #: ZS-LBBPvsBVP
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study was designed to compare the acute effects of left bundle branch pacing (LBBP) with biventricular pacing (BVP) in patients with left ventricular ejection fraction (LVEF) <=35% with left bundle branch block (LBBB).

Description:

The metrics include electrocardiographic, echocardiographic and hemodynamic parameters to evaluate and compare LBBP with BVP for resynchronization therapy in patients with heart failure and LBBB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• NYHA class II-IV;

• LVEF <=35%;

• LBBB with QRS duration >=130ms.

Exclusion Criteria:

• moderate-to-severe aortic stenosis;

• frequent premature ventricular complexes;

• signi?cant peripheral vascular disease.

Related Conditions & MeSH terms

• Cardiac Pacing, Artificial
• Cardiac Resynchronization Therapy
• Heart Failure

Intervention

Procedure:
• left bundle branch pacing
left bundle branch pacing
• biventricular pacing
biventricular pacing

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic parameter LV dP/dt(max)	LV dP/dt(max) will be obtained during implant procedure.	1 hour
Secondary	Electrical synchrony parameters including QRS duration and QRS area	Acquired from EP system during procedure	0.5 hour
Secondary	Mechanical parameters including Ts-SD and IVMD	Acquired by an echocardiologist during procedure	0.5 hour